All recipes to boost inclusions

You start project in clinical research and you want to achieve your goals in terms of patient inclusions? As CRA or project manager, you are or you may have been faced with one or more investigators who do not include patients and you want to find solutions to increase inclusions? Here are our recipes to make your project a success.

Above all: AN-TI-CI-PA-TE!

As project manager, it is important to anticipate difficulties that might be encountered by investigators at the time of the implementation of the test and, upon the study design phase. You can particularly reflect in advance, in your action plan and report it in your risk management plan.

Step 1: During the drafting, surround yourself of the study documents

• When drafting the protocol, consult more experts and opinion leaders on the design and feasibility of the study. Incorporate their proposals in the protocol before finalizing and submitting it to the competent authorities
• Get ready a recruitment support to present the study to patients and give them the desire to speak to their investigator.

It could be a poster that the investigator will hang or flyer that he/she will deposit in his/her waiting room, a notice on a website or even in the mainstream media.

This support will allow your investigators to identify which patients he would not have thought at first or bring new patients in consultation. Any recruitment strategy of patients must be submitted to CPP for notice as well as recruitment materials used. Think about it!

• Prepare a booklet for the investigator. Indicate in the title of the study, the main objective, criteria for inclusion and non-inclusion and any important information for the selection or the inclusion of a patient. The investigator will then be able to keep this document in his office or in his coat to keep the study in mind.

Step 2: Anticipate the correct compensation

• Investigators should be paid to the height of the work performed: the more the study will require investment in terms of time and resources, the more the compensation will be high. This must be negotiated with your centers before signing contracts. If you plan too low remuneration, there are risks that investigators will eventually not include patients in the study.
• The single contract allows for additional compensation for each inclusion and / or in cases of achievement of objectives. This compensation can be assigned to multiple recipients. Find out about its future and use this new arrangement to encourage your investigators

Step 3: Select properly your centers

• Select your centers through a questionnaire or an appeal of feasibility through a screening visit.

• Choose investigators who have proven screening methods and who included patients in similar studies. Check if your company has already conducted such studies or ask the promoter the list of former investigators having worked on similar studies.

• Before you go to screening visit, ask your investigator to check in his database, the number of patients who meet the selection criteria. Ask him to prepare this pre-screening list before your meeting so you can evaluate his recruitment potential.

• At the screening visit, make sure that the investigator has the human and material resources necessary for the implementation of the study. Also check with him that he has not another ongoing studies that could compete with your project. Indeed, he must have time to devote to your clinical trial and his patients must be included in your project only.

• Present in detail the criteria for inclusion and non-inclusion to the investigator. Ask him what are the criteria that could affect his inclusions. This information goes to the promoter; there may still be time to change the protocol. Similarly, if the CPP or ANSM have requests for changes, come back to the investigators to see if this will have no negative impact on their recruitment potential.

• Assess the motivation of the investigator. Identify why he wants to participate in the study: the financial aspect, the prestige, the welfare of patients, the science? This will help you later to find the right arguments to convince him to devote time to your project.

• Make sure that the investigator has a good network of contacts in his center and with external colleagues. Ask him if he regularly communicates with this network during Multidisciplinary Consultation Meetings (MCM) for example. Indeed, he can find, through this, patients that he does not necessarily see himself in consultation.

• Well choose the country coordinating investigator of the study. He must have experience in clinical trials and leadership to motivate other principal investigators and encourage them to include.

• During your screening visit, if the investigator has promised to include 10 patients, do not hesitate to divide that number in 2 and to open other centers. He may encounter difficulties he did not expect (patient refusal, for example). One is never too careful

• Finally, if you notice that your recruitment potential in France is too small, you can propose to the promoter to open the inclusions to other countries. This will allow you to boost the inclusions.

Step 4: Encourage experience sharing

• During meetings for investigators, always invite CSCs of centers. They are the actors of the selection and inclusion of patients. Through these meetings, they will be doubly formed to the study (the study will also be presented to them during the implementation) .They will have the opportunity to exchange with CSCs of other centers and will be able to share their experience and better understand the inclusions.

• Discuss with the team of the center before the implementation of the study: do they need specific tools to facilitate the implementation of this project? Create standard operating procedures and worksheets to help them with this project: this can be documents to help them record the concomitant treatments, to report and monitor adverse events, ordinances specifically planned for the trial to give back to investigators, specific manuals for CSCs or nurses… The goal? Avoid that the team encounters difficulties in the implementation of the study and this has an impact on inclusions.

Step 5: Encourage the screening of patients before the implementation and follow the evolution of inclusions week after week

Two weeks before the implementation of the study, ask your investigator to prepare another pre-screening list. This will allow them to get a list of patients ready and they can begin inclusions immediately after the establishment of the center.

• It is interesting to plan reminder for investigators to quickly identify the difficulties they may encounter and implement appropriate actions. You can also answer questions and remind them of the existence of your study.

• Request a list of patients and the date of the next visit of these patients. Note well that information and contact later the center the day after the arrival of patients to know the status of the current selection.

• Remind regularly the criteria for inclusion and non-inclusion and procedures to include a patient.

• From time to time, confirm the number of patients that the center planned initially to include.

Show yourself available to the investigator, he must feel supported and that the project team is ready to help in case of difficulties.

Step 6: Communicate on your study

Write a newsletter. A newsletter is a document that can be sent by email or post to investigators participating in your study. It may contain general information on the study as well as elements regarding the progress of the study: number of open centers, number of patients included; the investigators having included more patients in the study … you can create thanks to this document, a competitive dynamic in order to reach a larger number of inclusions.

And if, despite your efforts, do not include your centers do not include?

Step 1: Identify the cause

During contacts with your center, discuss with the investigator to understand why he did not include patients in the study. The causes can be numerous and identify them will enable you to implement the right solutions.

Step 2: Actions to be implemented

In case of too binding protocol:

Identify precisely what causes problem to the investigator. If several centers face similar difficulties, perhaps a protocol amendment will be discussed with the promoter.

In case of lack of eligible patients:
You can suggest to the investigator and his team to get in touch with associations of patients to tell them about the study.

In case of lack of time or organization:
Perhaps it is possible to put a CSC available to help to screen patients who might be included in the study.
In case of lack of interest or lack of motivation on the part of the investigator:
Several solutions can be implemented in order to motivate:

• Release the wages for the first patients included. Take advantage of a newsletter to announce to all investigators that wages will begin. This may motivate the investigators, who have already included, to include more and investigators who have not included to include their first patient.

• Communicate about the study. If you already have the results of the study, why not go and present them to the scientific community? Get information about the different conferences that take place in your specialty. Often, you can submit Abstracts. Plan an oral communication or a poster. If your project has been accepted for these conferences, talk to your investigators.

• Suggest to your promoter, the country coordinating investigator or a member of the scientific committee to contact your investigator. Thus, they will discuss the challenges and find appropriate solutions.

• You can also organize a monitoring visit in the presence of a member of the promoter or project manager. This will allow the investigator to meet members of the team and to discuss directly this lack of inclusions.

If your center does not include despite the actions implemented, this means that it will include no more. You can possibly think of closing the center and open others.

As project manager, anticipate difficulties and prepare upstream actions by writing them in your risk management plan in order not to be caught unaware.

As CRA, communicate with your investigators and their teams to find out as quickly as possible the problems and implement corrective actions. Finally, be always courteous, available and motivated. You have to convince the investigators that it is worthwhile to provide time to your project. Remember, your role is to motivate the team of your center, remind them the study or help them in the implementation of the project.

Now your turn!

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